NCT05480280

mFOLFOX6 Combined With Dalpiciclib in Patients With Metastatic Colorectal Cancer

mFOLFOX6 Combined With Dalpiciclib(SHR6390) in Patients With Metastatic Colorectal Cancer (FIND): A Single-arm, Phase IIa Study.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an prospective, single-center, single-arm, Simon's two-stage design, phase IIa study for advanced/metastatic colorectal cancer (CRC) who had failed or were intolerant to standard treatment. This study aims to evaluate the safety and efficacy of mFOLFOX6 combined with dalpiciclib (SHR6390) in the treatment of advanced/metastatic colorectal cancer.

Detailed description

1. Primary study end point: To evaluate the safety and objective response rate (ORR) of mFOLFOX6 combined with dalpiciclib (SHR6390) in patients with advanced/metastatic colorectal cancer who had failed or were intolerant to standard treatment. 2. Secondary study end Point: To evaluate the progression-free survival (PFS) and overall survival (OS) of mFOLFOX6 combined with dalpiciclib (SHR6390) in patients with advanced/metastatic colorectal cancer who had failed or were intolerant to standard treatment.

Conditions

• Advanced/Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Dalpiciclib	Dalpiciclib is orally administered at 125mg qd for 21 days and discontinue for 7 days.
DRUG	Oxaliplatin injection	85mg/m², ivdrip, D1
DRUG	Calcium folinate	400mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1
DRUG	5-fluorouracil	400mg/m², iv, D1; and 2400mg/m², civ, 46-48h

Timeline

• Start date: 2022-07-20
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-07-29
• Last updated: 2023-02-28

Locations

1 site across 1 country: China